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510(k) K850791

MDI 2000 - PULSE GENERATOR by Micromedical Devices, Inc. — Product Code DRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1985
Date Received
February 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device Class
Class II
Regulation Number
870.5550
Review Panel
CV
Submission Type

Other clearances by Micromedical Devices, Inc.

  • K043287 — PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 (December 10, 2004)
  • K936195 — LAPAROSCOPES (August 17, 1994)
  • K936155 — ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA (April 11, 1994)
  • K936097 — VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL (March 31, 1994)
  • K936086 — STERILE VIDEO CAMERA COVER AND DRAPE (March 17, 1994)
  • K834262 — TRANS-PACE (February 4, 1984)

Other clearances for product code DRO

  • K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (October 12, 2001)
  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 (September 15, 1999)
  • K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (September 15, 1999)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K961138 — ESORT II + 400 SERIES MONITOR (December 10, 1996)
  • K951593 — LIFEPAK 11 (December 29, 1995)